MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRX43902

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual sample was received for evaluation.Visual inspection revealed some clots adhering to the venous filter in the reservoir at around 250 - 400ml on the graduation.The amount of the clots seemed to have become small in comparison to those seen in the provided photo.It is likely to be because the actual sample was rinsed with water by the user.The venous and cardiotomy filters were taken out of the hard shell and cut open for further inspection.Visual inspection found clot adhesion on the outer surface of the venous filter.The filter components were inspected respectively under electron microscope.All the components were confirmed to have the normal mesh structure.The actual sample did not have any inherent deficiency which could have been a trigger of the clot formation.A photograph was provided by the user facility.A review of the photo confirmed the reported event; some film-like clots were noted to be adhering to the venous filter circumferentially at 300ml of the solution level.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: do not reduce heparin during circulation.Otherwise, blood clotting might occur.Adequate heparinization of the blood is required to prevent it from clotting in the system.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.As the actual sample was rinsed with water by the user and the original state of the clot formation has not been saved, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox custom pack was used during an arch aorta partial replacement procedure.The extracorporeal circulation started at 11:59.A little past 16:00, when blood was sent to the patient, the user found some large clots adhering to the venous filter inside the reservoir, at around 150 - 350ml on the graduation.At 17:56, the patient was weaned off bypass and transferred to pcps.Around 18:10, ascending aorta replacement was decided on.The user decided to change out the actual reservoir sample to a new one.After the change-out, the actual reservoir sample was rinsed with water; then the clot became smaller.Only the reservoir was changed out to a new one.The patient was not harmed.The procedure outcome was not reported.Review of the involved perfusion record found that there had been a blood transfusion and an administration of meylon, bicarbonate ringer's solution and transamin.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8920271
• MDR Text Key: 157872348
• Report Number: 9681834-2019-00146
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CX-XRX43902
• Device Lot Number: 190325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other